Date: Sun, 07 Apr 1996 13:37:29 -0700 (PDT)
From: "John S. James"
Subject: AIDS Treatment News #244
AIDS TREATMENT NEWS Issue #244, April 5, 1996
phone 800/TREAT-1-2, or 415/255-0588
CONTENTS:
San Francisco: 3TC Available Now to Residents through ADAP
Program
Protease Inhibitors: Patient Education Critical
Indinavir (Crixivan(R)) Access and Distribution
AIDS Research at NIH: Study Panel Issues Major Report
Viral Load: Inconclusive FDA Hearing
AZT, ddI, and ddC Combinations at FDA Advisory Hearing
Cidofovir Recommended for Approval for CMV Retinitis
California: Clinical Trials Computer Service Now Available
Statewide
San Francisco Protest Against Meeting Disruptions
California: AB 2812 Would Outlaw Anonymous Testing
AIDS Medications Needed Abroad
***** San Francisco: 3TC Available Now to Residents through
ADAP Program
In San Francisco the Mayor's HIV Planning Council found money
unspent on other AIDS programs and used it to cover
lamivudine (Epivir(TM), 3TC) under the ADAP program (AIDS
Drug Assistance Program, for persons with limited income).
The money, $900,000, should last for the several months which
it is likely to take for California to add the drug to the
statewide ADAP formulary. 3TC was added to the ADAP formulary
for San Francisco residents on April 1. (The unspent money
totaled $1.5 million; besides the $900,000, $285,000 was
allocated to vouchers for food, clothing, taxis, and
household necessities, and the remainder went to food
programs.)
Despite early reports to the contrary, San Francisco
residents DO NOT need to already be in the ADAP program to be
eligible for Epivir. They can join the AIDS Drug Assistance
Program now. They must be San Francisco residents, be HIV
positive, and qualify under fairly generous income limits.
Also, initial reports that only the tablets are covered were
erroneous; the oral solution, which is mainly for pediatric
use and also for adults who need to use doses lower than
usual, is covered by this program as well.
***** Protease Inhibitors: Patient Education Critical
by John S. James
It is widely agreed that successful use of the new protease
inhibitors -- especially indinavir (Crixivan(R)) from Merck &
Co., and ritonavir (Norvir(TM)) from Abbott Laboratories --
will depend on effective patient education. This education is
not yet in place; for example, some important materials are
not ready yet, and some are ready but not being distributed
successfully.
One major concern is drug safety, especially drug
interactions with Abbott's ritonavir. Many drugs must not be
taken together with ritonavir, because ritonavir prevents
those drugs from being metabolized by the body, resulting in
a large overdose (not of ritonavir, but of the other drug).
Abbott has prepared a card for patients to carry, listing
some of the most important drugs to avoid; unfortunately this
card has not yet been distributed with many of the
prescriptions dispensed so far. Therefore, we are reproducing
it below, with permission [not reproduced online]. But be
sure to check with your doctor, because this list is not
complete, and it will probably change as new interaction
problems are discovered. (Merck's indinavir seems to cause
much less problem with drug interactions and with side
effects, although there are some of each.) And the different
protease inhibitors MUST NOT be combined until clinical
trials have shown whether, and how, this might be done
safely.
The other major concern, with both Merck's indinavir and
Abbott's ritonavir, is that the drugs must be used properly,
or viral resistance will develop rapidly -- and once
resistance develops to either of these drugs, then both are
likely to be much less useful (if useful at all) for that
patient, at any time in the future. (With the only other
protease inhibitor which is now approved -- saquinavir
(Invirase(TM)) from Hoffmann-La Roche -- resistance seems to
develop more slowly, so the problem is not so critical.)
Because of the resistance problem, past practices such as
casual dose reductions, "drug holidays," or general laxity in
following instructions, must now be changed with the Merck
and Abbott drugs. Compliance with instructions on
prescription drugs is always a problem, and there is much
concern that patients may not comply closely enough to use
these new drugs effectively.
Also, resistance can be minimized and patients can get
maximum benefit from these drugs if they are used in
combination with other approved antiretrovirals; this keeps
the overall level of viral replication at a minimum, and
reduces the chance that a mutant virus will be resistant to
all the drugs. One combination of interest is indinavir plus
AZT plus 3TC. But combinations are likely to work best when
all of the drugs are new to the patient, so that the virus
has never seen any of them before. Since many patients have
already taken AZT for a long time, and may have virus
resistant to it, other combinations might be better for them.
Research is urgently needed to learn more about which
combinations are best for which patients.
For these reasons we believe that if people are doing fairly
well and can afford to wait, they should consider waiting
before starting protease inhibitors. In the next few months,
more will be learned about longer-term safety, and how to use
these drugs most effectively. Since most or all HIV drugs are
likely to work best the first time they are started (due to
the absence of resistant virus), it may be worth waiting in
order to get the maximum benefit out of one's first exposure
to these drugs.
But many people cannot afford to wait. If you do plan to
start using Merck's indinavir within the next few months,
while supplies are limited, you may want to start as soon as
possible, in order to have the best chance of obtaining this
drug -- see article below. (There seems to be no supply
problem with Abbott's ritonavir, however, and therefore no
occasion to hurry to get in line for it.)
***** Indinavir (Crixivan(R)) Access and Distribution
by John S. James
Because Merck will have limited supplies of indinavir
(Crixivan), its recently approved protease inhibitor, until
new factories are running this fall -- and because this drug,
once started, should not be interrupted, in order to avoid
giving the virus opportunities to become resistant -- Merck
has set up a complex temporary distribution system. The
purpose of this system is to make sure that there is enough
drug to provide refills to everyone who starts using it.
There may be enough supply for everyone; but if there is not,
Merck will have to put new people on a waiting list, to save
enough drug to continue those who have already begun. (If
supplies do run short, Merck plans to reserve enough drug for
about 2,500 people with CD4 (T-cell) counts under 50.) Merck
now has enough drug to supply about 30,000 persons in the
U.S. for the next several months, until the new factories are
ready. (This number is likely to change depending on
international approvals and demand.)
Because of the need to track prescriptions, and because Merck
does not have the inventory available to spare enough drug to
fill the standard pharmaceutical distribution pipeline, Merck
will temporarily sell indinavir only through one mail-order
pharmacy, Stadtlanders (hotline for Crixivan, 800/238-1548)
-- and by certain special arrangements otherwise. The rest of
this article will outline how the distribution system is
supposed to work, including how Merck plans to handle a
number of special cases -- certain states, various HMOs,
Medicaid, ADAP, Federal institutions, patients in hospitals,
and persons now taking indinavir in SOME of Merck's clinical
trials (who will be offered free drug for three to five years
for a followup study, and therefore will not need to buy it).
* Patients who are already using Stadtlanders, or whose
insurance allows them to use it, should have no problem. A
simple form will be required to start a new prescription, but
the paperwork is not difficult -- and Stadtlanders has a good
reputation for customer service and followup.
Merck is encouraging physicians and patients to submit their
initial forms by fax -- although prescriptions by mail and by
phone will also be accepted. (In New York City, Stadtlanders
has opened a pharmacy in order to qualify to do mail-order
business in New York State under certain laws. But patients
still must enroll through the main phone number. Our
understanding is that the New York store will be used mainly
for mailing prescriptions to New York State Medicaid
recipients -- and for local people who may prefer to have
their prescription mailed for them for pick up there, instead
of to their home.)
The disadvantage for Stadtlanders' customers -- and for
everyone else -- is the price; Stadtlanders has a monopoly
for the next several months, and patients who pay out of
pocket for their indinavir will have to pay $5820 per year --
a markup of more than 32% over the $4400 per year which Merck
charges Stadtlanders. This is more than $1400 per year just
for the filling of the prescription (plus associated user
services, such as direct insurance billing, and calling
customers to remind them when their prescription is about to
expire). Stadtlanders told us that most of their customers
will pay prices set by their health plan, not by
Stadtlanders.
Stadtlanders also told us that their retail price has been
set at average wholesale price plus 10%. But since there are
no wholesalers in this case, with Stadtlanders buying the
drug from Merck and selling it directly to the patient, it
appears that the division between average wholesale price and
retail markup is at whatever point Stadtlanders wishes to
pick. (The "average wholesale price" is $15, which is a 25%
markup over Merck's price to Stadtlanders -- an average
wholesale price markup which we have been told is unusually
high for the industry.)
Merck says that antitrust laws prevent it from negotiating a
price with Stadtlanders, or from bringing any pressure on
that company to lower its price. (We talked to one lawyer
familiar with antitrust, who said that while Merck is correct
that attempts at vertical price fixing are unlawful, an
exclusive distributorship agreement may be unlawful if it
decreases competition without some other procompetitive
justification.)
* At least two other mail-order pharmacies -- Community
Prescription Service (800/842-0502), and MedExpress (800/808-
8060) have announced that they will accept orders for
indinavir, and do the paperwork to get the drug through
Stadtlanders. Others may follow, since otherwise they risk
losing much of their business to Stadtlanders, as their
clients who have to go there for indinavir may take their
other prescriptions there too, to avoid having to deal with
separate mail-order pharmacies.
* For persons in HMOs, Merck is negotiating with the HMOs and
is finding that almost all of them are willing to work with
Stadtlanders. Merck does not expect much access problem for
persons in managed care. No HMOs so far have declined to
provide indinavir -- although many have not yet made a
decision.
* For a few staff-run HMOs like Kaiser, Merck has agreed to
supply the drug directly under certain conditions, not going
through Stadtlanders. Kaiser has already received indinavir
at this time.
* For Medicaid patients, Stadtlanders is a licensed provider
in 22 states and the District of Columbia -- accounting for
over two thirds of all patients who would be placed on
therapy. In the other states, Stadtlanders is working with
The Medicine Shoppe to distribute the drug. Stadtlanders will
still get the forms, monitor patients, and report to Merck,
but will ship each patient's drug to The Medicine Shoppe,
which will then re-ship it to the patient. As of April 1, 21
states currently plan to cover indinavir, and others are
making their decisions.
* For ADAP, like Medicaid, Stadtlanders will work with the
ADAP in states where Stadtlanders cannot provide the drug
directly to determine an acceptable method of counting and
tracking patients.
* For long-term care institutions, Stadtlanders will again
act like a wholesaler. The long term care provider will need
to count and track patients and provide these numbers to
Merck.
* Federal institutions -- the Veterans Administration, the
military, the National Institutes of Health, the Public
Health Service, and Federal prisons -- will get indinavir
directly from Merck. The drug was added to the Federal supply
schedule on April 1. These institutions will have the
responsibility of tacking and counting their patients and
reporting these numbers to Merck.
* Hospital inpatients will need to take their own indinavir
into the hospital, where it will be dispensed by the hospital
pharmacy. Large AIDS hospitals will also be allowed to buy
one bottle for emergency use, for example when a patient
forgets to bring the drug when being admitted.
Note: For all users of indinavir, Merck is now preparing a
patient package insert to explain how to use the drug
correctly. But this document needs approvals from within
Merck, and then from the FDA, before it will be released.
Payment Assistance Program
Persons who have no other way to pay can apply to Merck's
patient assistance program, called SUPPORT(TM), which will
help to find payment sources the patient may have overlooked,
help advocate with payers if necessary -- or as a last resort
provide free drug to those who meet certain financial
criteria, which Merck will not reveal.
But Merck has set a policy that if a state's ADAP program
decides not to cover indinavir, then Merck will not let new
patients in that state into its patient assistance program,
no matter what their financial need. Merck is applying this
policy to all insurance programs; if an HMO or insurance
company declines to pay for indinavir, then Merck will not
let any of that plan's patients start receiving the drug
through its patient assistance program. The company is
concerned that otherwise payers will refuse to pay for its
drug, with the argument that Merck will pick up the people
who could not possibly pay out of pocket.
But if someone is already on indinavir when their state or
their plan announces that it will not pay, it would then be
clearly unethical to cut them off, so Merck will continue
them in the program in that case. (This means that if someone
has already decided that they need indinavir -- and they
might qualify for free drug under the patient assistance
program because they have a low income -- they may be able to
get into that program now, before their state or plan makes
the decision, but not be able to get in later, if their plan
should decide not to pay).
Persons in Indinavir Clinical Trials
In order to collect long-term data on indinavir use, Merck
will offer free indinavir to persons who have been in most of
its phase II and one of its phase III studies, by extending
those studies for three to five years. The phase II trials
are: protocols 004, 006, 010, 018, 019, 020, 021, 025, and
035; and the phase III trial is protocol 039. Volunteers in
these studies can get free indinavir, so they will not need
to buy it.
Those in other Merck trials (such as 033 and 037) will be
"transitioned to commercial distribution" when these trials
end as planned. This transition usually includes at least
eight weeks of free open-label drug, giving people time to
decide if they want to continue the treatment, and to make
arrangements to do so. Those in Merck's "Advanced AIDS
Program" (i.e., those who won the expanded-access lottery),
are being transitioned starting April 1.
To ensure that there will be drug supply for patients who
will be prescribed indinavir once they have completed their
study, patients will receive a card (sent by Merck to their
physician) with an 800 number on it. They must call the 800
number and give their name and social security number. The
call from the patient is important to help Merck plan for
their future drug refill needs. If a patient does not receive
this card soon, they should contact their physician.
About 12,000 persons with advanced HIV disease who failed to
win the lottery for Merck's expanded-access program are now
being sent letters explaining the distribution and patient-
assistance programs.
Comment
No one knows how well this complex distribution system will
work. Clearly it has lots of potential to work badly.
Fortunately it should be ended within a few months, allowing
indinavir to be distributed through normal channels, with
normal competition to reduce the distribution cost.
We received much of the above information on April 1, two
days before going to press, so we have had no time to deal
with many concerns, including ethical issues, which need
larger public discussion. Is it OK for Stadtlanders to be
given an absolute monopoly of a life-critical drug, be
allowed to set whatever price it wants, and then to use this
situation to set an unusually high markup? Is it OK for Merck
to wash its hands in the antitrust laws?
And what about Merck's cutting off entry to its indigent-
patient program, no matter what one's financial need, because
one's insurance plan or state ADAP program refused to pay for
indinavir? Everyone knows that the Federally funded state
programs are going to run out of money. Persons with critical
illnesses are being used as pawns in this payment dispute
among large institutions, and are being forced to take the
loss when the institutions choose not to reach agreement.
And Merck appears to be mistaken in its apparent belief that
this cutoff policy will be necessary to get the drug paid
for. Any refusal to pay for indinavir, either by private
insurance or ADAP, will not only hurt the poor, but also be a
serious hardship for many middle-class persons who would not
qualify for free drug under the patient-assistance program in
any case. Since the poor have the least political influence,
their loss as advocates for indinavir coverage would be a
disproportionately small loss of the total constituency for
reimbursement.
Also, this distribution program is full of inefficient
special arrangements which exist only to avoid crossing the
letter of some law or rule -- rules instituted with or
without good intentions, but in either case with no
comprehension of how they would actually apply in this case.
Is this bizarre and wasteful outcome just part of the price
we pay for living under an organized society and rule of law?
Or is some fix possible? Would it be different if there were
the kind of widespread political support that would certainly
exist if AIDS struck randomly at anybody?
The ultimate issue is the political failure of this country
to create a workable healthcare system. No one knows how to
transform more than half a trillion dollars of greed into
something people can live with.
***** AIDS Research at NIH: Study Panel Issues Major Report
by John S. James
On March 14 the Office of AIDS Research of the U.S. National
Institutes of Health (NIH) released an overview evaluation of
AIDS research at NIH, conducted by 114 outside experts and
representatives under Princeton virologist Dr. Arnold Levine.
A number of subpanel reports are still confidential, but are
expected to be released in April. (This writer was a
community representative on one of the subpanels, on
complementary and alternative treatments.)
The overall report (REPORT OF THE NIH AIDS RESEARCH PROGRAM
EVALUATION WORKING GROUP OF THE OFFICE OF AIDS RESEARCH
ADVISORY COUNCIL) is by far the most important ever on AIDS
research. (It is limited to U.S. National Institutes of
Health, but the U.S. funds 85% of all publicly funded AIDS
research in the world.) The evaluation's conclusions and
recommendations are unusually strong for the scientific
world, which usually covers for each other's inadequacies and
mistakes. The report is being greeted with near-universal
enthusiasm among AIDS organizations and advocates -- and
panic from some researchers who fear their funding will be
cut.
One crucial document -- the report from the clinical trials
subpanel -- is still confidential. We have heard that it will
be less threatening to pediatric researchers than the overall
report which has been published. A major controversy around
pediatric AIDS research is that it has been
disproportionately funded due to a Congressional mandate. But
there is also recognition that the area does need special
government attention, since pharmaceutical companies have
been remarkably negligent in conducting pediatric studies.
When the rest of the documentation is available, we will
report in depth on this review of AIDS research. An important
article on the initial document appeared in THE NEW YORK
TIMES on March 14.
An immediate issue is the moves in Congress to take away the
central budget authority of OAR over NIH AIDS research
(authority which Congress gave OAR in 1993 when it last
reauthorized NIH) -- returning this authority to the separate
Institutes. There is widespread concern that this change
would prevent the panel's recommendations from being
implemented, and lead to a continuation of poor overall
management and uncoordinated research efforts.
You can get a copy of the report from the World Wide Web; go
to the NIH home page, http://www.nih.gov/, and look under
News and Events. Or call 301/402-3357; or mail a request
(including your address and phone number) to Office of AIDS
Research, Building 31, room 4B54, National Institutes of
Health, Bethesda, MD 20892-2340. You can also stop by that
office for a copy.
***** Viral Load: Inconclusive FDA Hearing
by John S. James
On March 21, the FDA's Blood Products Advisory Committee
(plus members of the Antiviral Drugs Advisory Committee, the
group which usually reviews AIDS issues) met to discuss the
first application for formal FDA approval of a viral load
testing kit, for the Amplicor HIV Monitor(TM) assay of
Hoffmann-La Roche. There was little community input at this
hearing -- not because of lack of interest, but because it
was widely believed that viral load is almost certain to be
approved anyway, so community support would not be necessary.
(Viral load has long been available without formal approval,
but approval would be advantageous for a number of reasons.)
But now there is concern that while the FDA is indeed likely
to approve viral load tests, it may approve them for
prognosis only -- which managed care and insurance companies
could use as an excuse to pay for no more than one or two
tests in a patient's lifetime. That, of course, would not be
the way practicing physicians want to employ these tests.
Many physicians see them as essential for effective use of
the protease inhibitors, and for making intelligent choices
among the far greater number of combination regimens now
becoming available. But this view was not well represented at
the FDA's hearing. Some activists are now concerned that the
FDA may be about to make a serious mistake, by discouraging
the use of viral load testing to help in choosing the best
antiviral regimen for each patient.
Sometimes scientific confusion is really the projection of a
political landscape beneath. We are preparing a longer report
on the current status of viral load.
***** AZT, ddI, and ddC Combinations at FDA Advisory Hearing
by John S. James
The February 28 meeting of the FDA Antiviral Drugs Advisory
Committee asked whether the recently-available results of
four major clinical trials should change the standard use of
AZT (Retrovir(R), zidovudine), ddI (VIDEX(R), didanosine),
and ddC (HIVID(R), zalcitabine) -- especially combination use
of these antiretrovirals. Specifically, the FDA asked:
"(1) Do the results of ACTG Study 175 and the other studies
[the Delta trials, CPCRA 007, and ACTG Study 152 -- which
tested various treatment approaches with AZT, ddI, and
sometimes ddC] support the safety and efficacy of didanosine
as initial therapy in persons with no prior history of
antiretroviral use? [Note: The current FDA-approved
prescribing information for didanosine (ddI) recommends that
AZT be tried first.]
"(2) Do the results of these studies provide evidence that
didanosine in combination with zidovudine is clinically more
effective than didanosine monotherapy? In your discussion,
please include comments on treatment of persons with and
without a prior history of antiretroviral use.
"(3) Do the results of ACTG Study 175 and other studies
support a traditional approval of HIVID (ddC) in combination
with Retrovir [AZT]." [Note: ddC is currently approved for
combination use with AZT, under the FDA's accelerated
approval regulations. This means that the combination has
demonstrated benefit through markers of HIV disease
progression such as viral load or CD4 count, but the
developer, Hoffmann-La Roche, was expected to do further
clinical trials to demonstrate direct clinical benefit to
patients, such as increased survival or reduced incidence of
opportunistic infections. The FDA asked the advisory
committee to discuss and vote on whether newly available
clinical-trial results have sufficiently demonstrated
clinical benefit.]
These questions led to long and complicated discussions. Two
analyses, one of the survival data from ACTG 175, the Delta
trials, and CPCRA 007, and another based on an overview of
seven studies of ddI and AZT, compiled by Jim Neaton, Ph.D.,
of the University of Minnesota, and others, suggested that:
* Overall both AZT+ddI and AZT+ddC were better than AZT alone
in reducing the risk of death. In each of the four
combination nucleoside studies considered, the reduction in
risk of death (compared to AZT monotherapy) was greater with
AZT+ddI than with AZT+ddC.
* The effects of ddI and AZT on survival were similar both
overall and in patients who were antiretroviral naive. This
analysis included ACTG 175 but did not include ACTG 152,
which was presented for the first time the same day. (ACTG
152 is a pediatric trial in which children on AZT alone did
worse than those on at least one of the other treatments,
resulting in early closure of the AZT monotherapy arm of the
trial.)
* There are not enough data to know whether or not AZT+ddI is
more effective than ddI alone in reducing risk of disease
progression and death.
On the FDA's questions:
* The Committee voted unanimously Yes on #1, indicating that
ddI should be approved for initial treatment of HIV disease.
* The Committee voted No on #2 (meaning that there is no
proof that ddI+AZT is better than ddI alone). But the
Committee was uncomfortable with this vote, fearing that many
patients would be denied combination treatment when it is
generally believed that combination treatment is best and has
become the standard of care. It also seemed "bizarre" to fail
to recommend approval of AZT+ddI, when the Committee was
clearly prepared to recommend approval of AZT+ddC, and when
many believe that AZT+ddI is at least as good as AZT+ddC.
* On question #3, the Committee unanimously voted to
recommend approval of AZT+ddC for antiretroviral-naive
persons, and unanimously voted against approval for
antiretroviral-experienced persons.
[Note: In support of ddI, Bristol-Myers Squibb pointed out in
a February press release that it is less expensive than AZT
or other antiretrovirals, and will soon be available in a new
tablet which is easier for patients to use than the
formulation available until now in the U.S.]
Comment
The discussion above needs to be kept in perspective. Today
it is widely believed that 3TC is better than either ddI or
ddC for use in combination with AZT. But there is no
clinical-endpoint data on this combination yet -- only viral
load and CD4 counts -- which is why 3TC was not considered at
the February 28 hearing.
Also, all of the discussion outlined above dealt with
averages, when really there is no such thing as the average
patient. Averages may suggest which treatment to try first,
when there is no better way to guess. But if viral load tests
or other indications suggest that a treatment is not working
well for an individual, other treatments can quickly be tried
instead.
[Note: AIDS TREATMENT NEWS did not attend the February 28
hearing, and acknowledges the assistance with this article
from Mark Mascolini and from Dr. Jim Neaton.]
***** Cidofovir Recommended for Approval for CMV Retinitis
by John S. James
On March 15 an FDA advisory panel unanimously recommended
approval of cidofovir for injection (Vistide(R), also known
as GS 504 intravenous, and by its chemical initials HPMPC), a
new drug for treating CMV retinitis. Panel members were
concerned about safety and lack of long-term data; but they
voted for approval because the drug has proved effective
against a condition which urgently needs more treatment
options -- effective both in newly diagnosed patients, and in
those who had failed other therapies.
Cidofovir, being developed by Gilead Sciences of Foster City,
California, is given intravenously (in the trials considered
at this meeting); however, it is used only once a week for
two weeks, and then every other week after that, so it does
not require an implanted catheter (unlike ganciclovir or
foscarnet intravenous treatment). Note: Ganciclovir has now
been approved by the FDA as an eye implant, and as orally
administered capsules, for treating CMV retinitis in certain
patients, avoiding the need for a catheter.
The main safety concern with the new drug cidofovir is kidney
toxicity; another drug, probenecid, is used to reduce this
problem, and hydration is also necessary. In one trial, two
thirds of the volunteers had adverse reactions to at least
one of the drugs.
The other major concern is that in a laboratory study,
cidofovir caused cancers in the mammary glands of female
rats. It is not known if this problem occurs in people;
however, Gilead reported that no carcinogenicity was found in
a 52-week study in primates, and that there were no cases of
non-AIDS cancers in over 500 people who have taken the drug,
and their AIDS-related cancers were consistent with controls.
Very few women have taken cidofovir in trials, so the safety
for women is unknown.
Different formulations of cidofovir is also being tested for
direct injection into the eye, and as an eyedrop for other
infections, and as a topical gel for herpes and for genital
warts.
Cidofovir is now available free of charge in the U.S. and
Canada through an expanded access program for patients with
relapsing disease who have failed or are intolerant to either
ganciclovir or foscarnet. For more information about this
program, call 800/GILEAD-5.
Note: AIDS TREATMENT NEWS did not attend the March 15
hearing. This article is largely based on coverage in the
March 18 issue of BIOCENTURY (a weekly biotechnology
newsletter delivered by fax or email, published by BioCentury
Publications Inc., in San Carlos, California), and on March
11 and March 15 press releases from Gilead. Also note the
coverage March 19 in THE NEW YORK TIMES, of a large initial
drop in Gilead's stock price which occurred when a reporter
stepped out of the meeting early and headlined old data about
the tumors in rats.
***** California: Clinical Trials Computer Service Now
Available Statewide
Trials Search, which matches a patient's confidential medical
information to over 100 HIV-related clinical trials in its
database and finds the ones for which the patient is
qualified, has been available without charge in the San
Francisco area since 1991 but is now being expanded
throughout the state. Patients complete a two-page
questionnaire giving their medical status and contact
information, and receive a list of open trials which they are
likely to be eligible to join.
Trials Search, originally developed in 1991 at Ralph K.
Davies Medical Center in San Francisco, is now operated by
the Community Consortium, an association of more than 200
physicians and other health-care professionals who provide
care for a majority of patients with HIV disease in the nine
San Francisco Bay Area counties. The expansion of the service
to Southern California was financed by the Kaiser Family
Foundation; however, the Community Consortium is still
seeking financial support for other Trials Search expenses.
Persons interested in receiving the questionnaire can call
either 800/492-5777, or 415/476-5777.
Also, the Community Consortium will make the Trials Search
software and database available to medical centers, AIDS
service organizations, and patient advocacy groups so that
searches can be done on site. In addition, the service will
be available to anyone through the Internet. (Currently it is
less useful outside of California, however, because the
database consists of trials which have sites within
California. But other medical centers could use the Trials
Search software, and enter their own database of the trials
available in their area.)
The Community Consortium also publishes the GUIDE TO HIV
CLINICAL TRIALS IN CALIFORNIA (both a Northern California and
Southern California edition), which provide in printed form
the same data in the Trials Search database. Both editions
are available now, and will be updated three times a year.
For a free copy of either guide, call either 800/492-5777, or
415/476-5777.
***** San Francisco Protest Against Meeting Disruptions
by John S. James
On April 4, over 25 leading AIDS activists and organizers in
San Francisco -- all of them persons with HIV -- published a
letter asking a group calling itself ACT UP San Francisco to
stop disrupting public forums on treatment options for AIDS
and HIV. About a half-dozen persons identifying themselves as
ACT UP San Francisco have targeted public forums of the
Community Consortium (a local medical association which
includes the physicians who treat most of the people with HIV
in the nine San Francisco Bay Area counties), and of Project
Inform and others.
This long-simmering controversy escalated with the disruption
of a Community Consortium meeting at Davies Hospital on March
16. A scuffle occurred before the police arrived to restore
order, and speakers Donald Abrams, M.D., and Paul Volberding,
M.D., were drowned out or unable to complete their talks on
viral load and other topics.
From an ACT UP San Francisco press release after the
incident: "'This game of promoting expensive, harmful drugs
by touting their temporary effects on dubious surrogate
markers like CD4 counts and blood viral load must stop now,'
demands ACT UP member Todd Swindell. 'We're dying while AIDS
research is held hostage by drug companies and the
virologists, clinicians and so-called AIDS advocates on their
payrolls. This isn't science; it's exploitation of the sick
in its most vile form.'" ("ACT UP SF Questions Turn Drug
Company Forum into Brawl in the Hall," ACT UP San Francisco,
March 17.)
From the April 4 activists' statement opposing the meeting
disruptions: "People with AIDS have the right to choose our
own sources of information and the wisdom to know whom to
believe. We are committing ourselves now to stop any such
disruptions in the future. We need your support... Please
contact the mayor, your supervisors, the Department of Public
Health, AIDS organizations, the media, forum presenters and
especially 'ACT UP SF'. Let them know you need safety and
treatment information."
A January 15 release from ACT UP San Francisco described an
earlier incident (against a Project Inform Town Hall meeting
on January 11, 1996) as part of a series: "The disruption was
the first in a planned series of attacks on mainstream AIDS
organizations in San Francisco that ACT UP SF has identified
as embroiled in conflict of interest through their acceptance
of pharmaceutical industry contributions."
Comment
The main concern has been that disruptions have been serious
enough to prevent information from being presented; people
leave and do not come back. Also, physicians and researchers
are becoming reluctant to speak in the San Francisco area.
The result is that people are prevented from getting
information they need for making treatment decisions.
ACT UP San Francisco can legitimately raise its issues,
including the excessive influence of pharmaceutical
companies, in the question and answer periods of community
forums, or by distributing flyers, or by holding its own
meetings. What is not legitimate is to prevent others from
getting the treatment information they have come to hear.
For more information on this controversy, you can obtain a
copy of the April 4 statement and list of signers from Ben
Collins, 415/558-8669, ext. 211. To reach ACT UP San
Francisco, call 415/522-2907, or call Michael Bellefountaine,
415/487-9954. Or see the debates on the Internet newsgroup
sci.med.aids -- including "Demean, Dupe, Dose, Die" (March
25, from "DaveACTUP," strongly supportive of ACT Up San
Francisco although not signed by that organization), and
replies from Martin Delaney and others. Delaney's March 28
reply addresses the substance of the scientific disputes, as
well as the allegations of pharmaceutical-company influence.
If you cannot easily get it by computer, a copy is available
from Ben Collins, or from the Project Inform hotline,
800/822-7422 or 415/558-9051, 10 a.m. - 4 p.m. Pacific time,
Monday through Saturday. (Project Inform also has a World
Wide Web site, http://www.projinf.org.)
Note: AIDS TREATMENT NEWS often reports on the treatment
activist work of ACT UP/Golden Gate (415/252-9200). ACT
UP/Golden Gate wants the public to know that it is not
affiliated with ACT UP San Francisco. ACT UP/Golden Gate
signed the April 4 statement, and also issued its own March
28 press release condemning the meeting disruptions.
***** California: AB 2812 Would Outlaw Anonymous Testing
by John S. James
A bill in the California legislature (AB 2812, Bondonaro,
Republican, Santa Barbara) would end anonymous testing in the
state by adding HIV infection to the list of diseases that
must be reported to the State Department of Health Services.
The practical result would be that many people will avoid
being tested, and miss early treatment if they are infected,
as well as missing the prevention education they would get no
matter how the test turns out. According to the Grass Roots
Networks of AIDS Project Los Angeles, "AB 2812 is sponsored
by the Capitol Resources Institute, an extremely conservative
lobbying group affiliated with Focus on the Family and State
Senator Rob Hurtt. These are the same folks that support
quarantine camps for all people living with HIV and AIDS!"
A hearing is scheduled for April 16 in the Assembly Health
Committee. You can help by writing to your California
Assembly representative opposing AB 2812, and by getting
others to do so.
For more information on this and other California issues, and
what you can do, call the Grass Roots Hotline at 213/993-
1680. It is a 24 hour voicemail information number, but it
lets you reach a person during business hours.
***** AIDS Medications Needed Abroad
Unused medications which otherwise would be discarded can be
a lifesaver in clinics which otherwise would not have access
to them. Recently we heard about three efforts to collect
medicines for clinics abroad.
For Guatemala, the Guatemalan Association to Prevent and
Control AIDS is seeking HIV-related medications for their two
clinics in Guatemala City. Bactrim, AZT, and other drugs are
needed. For more information, contact Matt Anderson, M.D.,
Montefiore Family Health Center, 718/933-2400 (voice mail
644), or by beeper at 917/556-5046.
For South Africa, if you have medicines to donate, leave a
message with ACT UP/Golden Gate, 415/252-9200. The South
African clinics do not need Bactrim, but do need many other
medications.
And to find out about donating medicines for Cuba, contact
Alfredo Martinez-Garcia, 407/932-4482, on weekdays. His group
also needs vitamins and antibiotics. They can accept outdated
medications because many companies will exchange dated
medications for new ones.
***** AIDS TREATMENT NEWS
Published twice monthly
Subscription and Editorial Office:
P.O. Box 411256
San Francisco, CA 94141
800/TREAT-1-2 toll-free U.S. and Canada
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fax: 415/255-4659
Internet: aidsnews@aidsnews.org
Editor and Publisher:
John S. James
Reader Services and Business:
Richard Copeland
Thom Fontaine
Denny Smith
Tadd Tobias
Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and
standard treatments, especially those available now. We
interview physicians, scientists, other health
professionals, and persons with AIDS or HIV; we also
collect information from meetings and conferences,
medical journals, and computer databases. Long-term
survivors have usually tried many different treatments,
and found combinations which work for them. AIDS
Treatment News does not recommend particular
therapies, but seeks to increase the options available.
Subscription Information: Call 800/TREAT-1-2
Businesses, Institutions, Professionals: $230/year.
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Special discount for persons with financial difficulties:
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ISSN # 1052-4207
Copyright 1996 by John S. James. Permission granted for
noncommercial reproduction, provided that our address
and phone number are included if more than short
quotations are used.